Catalent Initiated Changes Sample Clauses

Catalent Initiated Changes. Before Catalent may amend or change the Scope of Work, Catalent shall prepare a Change Order describing in reasonable detail the nature of such change(s) and propose such Change Order to Sarepta for Sarepta’s review and written approval. All approved Change Orders shall be approved and signed by the Project Manager of each Party or by such other authorized representatives of Catalent and Sarepta that the Project Managers may designate. If any changes contemplated by a Change Order will have a financial or other impact on the Scope of Work, Catalent shall include in the Change Order a written description of such impacts. If the authorized Sarepta Representative approves the Change Order notwithstanding Catalent’s notice of any resulting cost increase, Sarepta shall reimburse Catalent for the cost of such changes as detailed in the Change Order. Upon approval of the Change Order, the Change Order will be implemented [**] in a good faith effort to meet the development and manufacturing timelines as set forth in the Scope of Work.
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Catalent Initiated Changes. Catalent shall not make any revisions to the Specifications or to the manner of storing and handling materials used in the Manufacture of the Bulk Drug Substance or Drug Product or change the supplier(s) of Raw Materials, without prior written consent of Sarepta in accordance with the Quality Agreement. Sarepta retains the right and responsibility for final approval of the Specifications for Bulk Drug Substance and Drug Product, including in connection therewith the right to approve any changes in the manner of storing and handling materials and in the supplier(s) of Raw Materials. All requests by Catalent for such revisions shall be submitted in writing to Sarepta on the forms prescribed by the Quality Agreement in advance. Catalent shall notify Sarepta, in writing and in reasonable detail, of: (i) Catalent’s suggested change; (ii) the reasons for the suggested change; (iii) the perceived benefits of the suggested change to Catalent and Sarepta, respectively; and (iv) the estimated costs and timing of implementing such change. If the Parties implement a change in the Specifications hereunder, they shall negotiate any changes in any affected Purchase Order to provide reasonable accommodation for changed circumstances. Catalent shall be responsible for documenting all revisions to the Specifications, subject to Sarepta’s approval, in accordance with the Quality Agreement, as applicable. Catalent shall also support all applicable regulatory submissions in connection therewith and, at the request of Sarepta, address any questions or inquiries related thereto.

Related to Catalent Initiated Changes

  • SCOPE CHANGES The Commissioner reserves the right to require, by written order, changes to the scope of the Contract, by altering, adding to or deducting from the Bid Specifications, such changes to be within the general scope of the Contract. If any such change causes an increase or decrease in the cost of, or the time required for, performance of any part of the work under the Contract, whether or not changed by the order, the Commissioner shall, upon notice from Contractor as hereafter stated, make an equitable adjustment in the Contract price, the delivery schedule or both and shall modify the Contract. The Contractor must assert its right to an adjustment under this clause within thirty days from the date of receipt of the written order. However, if the Commissioner decides that the facts justify it, the Commissioner may provide an adjustment without receipt of a proposal. Failure to agree to any adjustment shall be a dispute under the Disputes clause, provided, however, that nothing in this clause shall excuse the Contractor from proceeding with the Contract as changed.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Service Changes PBI may modify its Service by giving written notice to you (a “Service Change Notice”), which will state whether the change is material. After receiving a Service Change Notice, if the change is material, you may terminate Service by giving us a termination notice at the address indicated in Section 21 or you may create a case at xxxxxxxxxxx.xxx/xx/xxxxxxx-xx.xxxx (follow the instructions under “how to create a case”).

  • Program Changes Contractor agrees to inform the County of any alteration in program or service delivery at least thirty (30) days prior to the implementation of the change, or as soon as reasonably feasible.

  • TECHNOLOGICAL CHANGES 29.01 Any significant technological changes affecting members or their work environment will be discussed between Management and the Association prior to implementation with a view to resolving any problems. Whenever practical, the Board, through the Administration of the Service, will commence such discussions at least three (3) months in advance of the planned change.

  • Implementation of Changes If Tenant: (i) approves in writing the cost or savings and the estimated extension in the time for completion of Landlord’s Work, if any, and (ii) deposits with Landlord any Excess TI Costs required in connection with such Change, Landlord shall cause the approved Change to be instituted. Notwithstanding any approval or disapproval by Tenant of any estimate of the delay caused by such proposed Change, the TI Architect’s determination of the amount of Tenant Delay in connection with such Change shall be final and binding on Landlord and Tenant.

  • Contractor Changes The Contractor shall notify DAS in writing no later than ten (10) Days from the effective date of any change in: a. its certificate of incorporation or other organizational document; b. more than a controlling interest in the ownership of the Contractor; or c. the individual(s) in charge of the Performance. This change shall not relieve the Contractor of any responsibility for the accuracy and completeness of the Performance. DAS, after receiving written notice by the Contractor of any such change, may require such agreements, releases and other instruments evidencing, to DAS’s satisfaction, that any individuals retiring or otherwise separating from the Contractor have been compensated in full or that provision has been made for compensation in full, for all work performed under terms of the Contract. The Contractor shall deliver such documents to DAS in accordance with the terms of DAS’s written request. DAS may also require, and the Contractor shall deliver, a financial statement showing that solvency of the Contractor is maintained. The death of any Contractor Party, as applicable, shall not release the Contractor from the obligation to Perform under the Contract; the surviving Contractor Parties, as appropriate, must continue to Perform under the Contract until Performance is fully completed.

  • CHANGES TO PRODUCT OR SERVICE OFFERINGS a. Product or Service Discontinuance Where Contractor is the Product Manufacturer/Developer, and Contractor publicly announces to all U.S. customers (“date of notice”) that a Product is being withdrawn from the U.S. market or that maintenance service or technical support provided by Contractor (“withdrawn support”) is no longer going to be offered, Contractor shall be required to: (i) notify the Commissioner, each Licensee and each Authorized User then under contract for maintenance or technical support in writing of the intended discontinuance; and (ii) continue to offer Product or withdrawn support upon the Contract terms previously offered for the greater of: a) the best terms offered by Contractor to any other customer, or b) not less than twelve (12) months from the date of notice; and (iii) at Authorized User’s option, provided that the Authorized User is under contract for maintenance on the date of notice, either: provide the Authorized User with a Product replacement or migration path with at least equivalent functionality at no additional charge to enable Authorized User to continue use and maintenance of the Product. In the event that the Contractor is not the Product Manufacturer, Contractor shall be required to: (i) provide the notice required under the paragraph above, to the entities described within five (5) business days of Contractor receiving notice from the Product Manufacturer, and (ii) include in such notice the period of time from the date of notice that the Product Manufacturer will continue to provide Product or withdraw support. The provisions of this subdivision (a) shall not apply or eliminate Contractor’s obligations where withdrawn support is being provided by an independent Subcontractor. In the event that such Subcontractor ceases to provide service, Contractor shall be responsible for subcontracting such service, subject to state approval, to an alternate Subcontractor.

  • Execution of Change Orders Change Orders shall be signed by the Contractor, ordinarily certified by the Design Professional, and approved by the Owner in accordance with the form of Change Order prescribed by the Owner. No request for payment by the Contractor for a Change Order shall be due, nor shall any such request appear on an Application for Payment, until the Change Order is executed by the Owner. In the event of emergency (see Article

  • SCOPE OF SERVICES/CASE HANDLING A. Upon execution by GPM, attorneys are retained to provide legal services for the purpose of seeking damages and other relief in the Litigation. Client provides authorization to seek appointment as Lead Plaintiff in the class action, while the Attorneys will seek to be appointed Class Counsel. If this occurs, the Litigation will be prosecuted as a class action. B. If you obtain access to non-public information during the pendency of the Litigation, you must not engage in transactions in securities. C. Attorneys are authorized to prosecute the Litigation. The appointed Lead Plaintiffs will monitor, review and participate with counsel in the prosecution of the Litigation. The Attorneys shall consult with the appointed Lead Plaintiffs concerning all major substantive matters related to the Litigation, including, but not limited to, the complaint, dispositive motions and settlement. Because of potential differences of opinion between Clients concerning, among other things, strategy, goals and objectives of the Litigation, the Attorneys shall consult with the appointed Lead Plaintiffs as to the courses of action to pursue. The Client agrees to abide by the decisions of the appointed Lead Plaintiffs, which shall be final and binding on all Clients. D. GPM is given the authority to opt the Client out of any class action proceeding relating to the claims authorized herein and/or pursue the Client claim individually in a group action, if the Client is not appointed Lead Plaintiff and GPM is not appointed Class Counsel. E. The Attorneys shall provide sufficient resources, including attorney time and capital for payment of costs and expenses, to vigorously prosecute the Litigation. F. Any recovery from defendants that the Attorneys are responsible for will be divided among class members based on the recognized loss by each class member as calculated by a damage allocation plan which will be prepared by a financial expert or consultant, provided to the appointed Lead Plaintiffs, be subject to the Court's approval and will account for such factors as size of securities ownership, date of purchase, date of sale and continued holdings, if any. Under the rules governing class action litigation, while the Lead Plaintiffs recover according to the same formula as other class members, the Court may approve, upon application therefore, reimbursement of the Lead Plaintiffs’ reasonable costs and expenses directly related to the representation of the class. Examples are lost wages and travel expenses associated with testifying in the action.

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